- QC Raw Material Release SME

תיאור תפקיד

We are looking for a proactive and experienced Quality Control Subject Matter Expert (SME) to lead and support raw material release activities and other QC related projects.
This role is critical for ensuring the integrity, compliance, and timely availability of raw materials for manufacturing, while actively driving improvements and working closely with quality, supply chain, and technical teams.

Key Responsibilities
Technical Leadership
•    Act as the SME for raw material testing, specifications, and release processes.
•    Provide guidance on analytical methods and pharmacopeial standards.
•    Lead troubleshooting and investigations related to raw material quality issues.
Quality Oversight & Compliance
•    Verify all raw materials meet internal and external quality standards before release.
•    Manage and support risk assessments and deviations related to raw materials.
•    Review and approve Certificates of Analysis (CoAs), test results, and related documentation.
•    Support audits and inspections by regulatory authorities.
Cross-Functional Collaboration
•    Work closely with Procurement, Supply Chain, Manufacturing, and QA to ensure smooth material flow.
•    Collaborate on risk assessments and change control for new or revised raw materials.
Continuous Improvement & Hands-On Activities
•    Identify and implement improvements in sampling, testing, and release workflows.
•    Write and approve testing protocols, reports and execute tests when needed.
•    Contribute to raw material lifecycle management.
•    Support digitalization and data integrity initiatives within the QC laboratory.

Qualifications
•    Bachelor’s degree in Chemistry, Life Sciences, or related field.
•    Minimum 2 years of experience in pharmaceutical QC, with a focus on raw materials.
•    Proven ability to lead cross-functional initiatives with a hands-on approach.
•    Strong communication, problem-solving, and organizational skills.
•    Familiarity with risk-based approaches to material qualification and release.
•    Practical experience in performing QC activities and writing of protocols and reports.
•    Assist in organizing received raw materials which may require some physical effort. 
•    Advantage: Knowledge of GMP and exposure to sterile or biologics manufacturing environments.

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